PART I—FINANCIAL INFORMATION Financial Statements For the quarter ended March 31, 2025, the company reported a net loss of $4.5 million, a decrease from the $8.1 million net loss in the same period of 2024, primarily due to a positive change in the fair value of warrant liability. Operating expenses increased to $5.4 million from $3.9 million year-over-year, driven by higher R&D and G&A costs. As of March 31, 2025, the company held $10.9 million in cash, an increase from year-end 2024, supported by $5.5 million in net cash from financing activities. However, with an accumulated deficit of $91.8 million and recurring losses, there is substantial doubt about the company's ability to continue as a going concern without raising additional capital Condensed Consolidated Balance Sheets As of March 31, 2025, the company's total assets increased to $11.9 million from $10.2 million at the end of 2024, primarily due to a rise in cash. Total liabilities also grew to $6.9 million from $6.5 million, while total stockholders' equity improved to $4.9 million from $3.6 million, reflecting recent financing activities Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash | $10,863,296 | $9,601,298 | | Total current assets | $11,861,852 | $10,152,479 | | Total assets | $11,864,652 | $10,155,279 | | Liabilities & Equity | | | | Total current liabilities | $5,057,511 | $3,830,038 | | Warrant liability | $1,864,616 | $2,690,605 | | Total liabilities | $6,922,127 | $6,520,643 | | Accumulated deficit | $(91,752,092) | $(87,234,833) | | Total stockholders' equity | $4,942,525 | $3,634,636 | Condensed Consolidated Statements of Operations For the three months ended March 31, 2025, the company reported a net loss of $4.5 million, or ($0.16) per share, compared to a net loss of $8.1 million, or ($0.46) per share, for the same period in 2024. The reduced net loss was primarily due to a $0.8 million gain from the change in fair value of warrant liability, compared to a $4.2 million loss in the prior year. Operating expenses increased by 37% year-over-year, driven by higher research and development and general and administrative costs Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development expenses | $3,197,532 | $2,320,742 | | General and administrative expenses | $2,227,899 | $1,628,134 | | Loss from operations | $(5,425,431) | $(3,948,876) | | Change in fair value of warrant liability | $825,989 | $(4,181,298) | | Net loss | $(4,517,259) | $(8,067,455) | | Net loss per share (Basic and diluted) | $(0.16) | $(0.46) | Condensed Consolidated Statements of Cash Flows For the three months ended March 31, 2025, net cash used in operating activities was $4.2 million. Net cash provided by financing activities was $5.5 million, primarily from private placements and at-the-market offerings. This resulted in a net increase in cash of $1.3 million, bringing the cash balance to $10.9 million at the end of the period Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,202,274) | $(3,586,800) | | Net cash provided by financing activities | $5,461,216 | $4,717,048 | | Net increase in cash | $1,261,998 | $1,120,754 | | Cash at end of period | $10,863,296 | $8,271,449 | Notes to Unaudited Condensed Consolidated Financial Statements The notes detail the company's accounting policies, including the significant risks and uncertainties related to its operations and need for future funding. Key disclosures include a going concern warning due to recurring losses and an accumulated deficit of $91.8 million. The company has engaged in multiple financing activities, including private placements and at-the-market offerings, raising significant capital. It has licensing agreements with potential milestone payments up to $112 million and clinical supply agreements with Regeneron and BeiGene. Subsequent to the quarter's end, the company conducted another private placement, raising approximately $1.08 million - The company has incurred recurring losses and has an accumulated deficit of $91,752,092 as of March 31, 2025. Management has concluded there is substantial doubt about the Company's ability to continue as a going concern within one year3637 - In February and March 2025, the company completed private placements, issuing a total of 2,762,633 shares and associated warrants, raising gross proceeds of approximately $4.1 million8688 - The company has patent licensing agreements with the University of Texas Southwestern (UTSW) that require potential milestone payments up to a combined total of $112 million for each of two agreements, plus royalties on net sales111112 - Subsequent to the quarter end, on May 8, 2025, the company sold 719,999 shares and warrants in a private placement for gross proceeds of approximately $1.08 million120 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's position as a clinical-stage biopharmaceutical firm focused on its lead asset, ateganosine (THIO), for treating cancers, initially Non-Small Cell Lung Cancer (NSCLC). The company highlights recent progress, including positive data from the THIO-101 Phase 2 trial, a new clinical supply agreement with BeiGene, and plans for a pivotal Phase 3 trial (THIO-104) in 2025. Financially, operating expenses rose 37% year-over-year due to increased clinical research and professional fees. The company acknowledges substantial doubt about its ability to continue as a going concern and details its reliance on recent and future capital raises, including private placements and at-the-market offerings, to fund operations Overview and Key Milestones MAIA is a clinical-stage biopharmaceutical company developing ateganosine (THIO), a targeted immunotherapy for cancer, with an initial focus on NSCLC. Key recent milestones include a clinical supply agreement with BeiGene for trials in three new cancer indications, positive updated data from the THIO-101 Phase 2 trial showing a median overall survival of 16.9 months in third-line NSCLC patients, and the official adoption of 'ateganosine' as the generic name for THIO. The company also announced plans for a pivotal Phase 3 trial (THIO-104) to begin in 2025 - The lead asset, ateganosine (THIO), is being evaluated in a Phase 2 trial (THIO-101) for Non-Small Cell Lung Cancer (NSCLC). The company plans to initiate a pivotal Phase 3 trial (THIO-104) in 2025123 - Entered a clinical supply agreement with BeiGene to evaluate THIO in combination with tislelizumab for hepatocellular carcinoma (HCC), small cell lung cancer (SCLC), and colorectal cancer (CRC)125 - Announced positive updated data from the THIO-101 Phase 2 trial, with a median overall survival (OS) of 16.9 months for third-line NSCLC patients as of January 15, 2025125 Results of Operations For the three months ended March 31, 2025, operating expenses increased by 37% to $5.4 million compared to the same period in 2024. Research and development expenses rose by 38% to $3.2 million due to increased scientific and clinical research activities. General and administrative expenses grew by 37% to $2.2 million, primarily from higher professional fees and investor relations costs. Other income, net, was approximately $0.9 million, a significant positive swing from an expense of $4.1 million in the prior year, mainly due to the change in fair value of warrant liability. This resulted in a reduced net loss of $4.5 million for the quarter Comparison of Operating Results | Expense Category | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $3,197,532 | $2,320,742 | $876,790 | 38% | | General and administrative expenses | $2,227,899 | $1,628,134 | $599,765 | 37% | | Total operating costs and expenses | $5,425,431 | $3,948,876 | $1,476,555 | 37% | | Net loss | $(4,517,259) | $(8,067,455) | $3,550,196 | (44)% | - The increase in R&D expenses was primarily due to an $873,000 increase in scientific and clinical research130 - The increase in G&A expenses was primarily related to a $649,000 increase in professional fees and investor relations131 Liquidity and Capital Resources As of March 31, 2025, the company had approximately $10.9 million in cash and $6.8 million in working capital. Despite recent financing activities, including raising approximately $5.5 million net in Q1 2025 from private placements and at-the-market offerings, the company's history of losses and negative cash flows raises substantial doubt about its ability to continue as a going concern. Management states that additional capital will be necessary to fund operations and commercialize its products, and there is no guarantee that such financing will be available on acceptable terms - As of March 31, 2025, cash totaled approximately $10.9 million. The company has generated no revenues to date134 - Management has concluded there is substantial doubt about the company's ability to continue as a going concern and will need to raise additional equity or debt financing135 - In Q1 2025, the company raised gross proceeds of approximately $4.1 million from two private placements and $1.5 million from its At-The-Market (ATM) offering139140141 Quantitative and Qualitative Disclosures About Market Risk The company is a smaller reporting company and is not required to provide the information for this item - As a smaller reporting company, MAIA Biotechnology, Inc. is not required to provide quantitative and qualitative disclosures about market risk155 Controls and Procedures Management, including the CEO and Head of Finance, evaluated the company's disclosure controls and procedures as of March 31, 2025. They concluded that these controls were effective at a reasonable assurance level. There were no material changes to the company's internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2025, the Chief Executive Officer and Head of Finance concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level156 - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls157 PART II—OTHER INFORMATION Legal Proceedings The company is not currently a party to any material legal proceedings. It may, however, be involved in ordinary course of business claims from time to time - The company is not party to any material legal proceedings159 Risk Factors The primary risk factor highlighted is the potential for the company's common stock to be delisted from the NYSE American. The company did not meet the exchange's minimum stockholders' equity requirement of $6 million as of December 31, 2024. While it currently complies with alternate listing standards related to market capitalization and public float, there is no assurance it can maintain compliance, and a delisting could severely limit liquidity and the ability to raise capital - A key risk is the potential delisting from the NYSE American for failing to meet the continued listing requirement of $6 million in stockholders' equity, as the company's equity was approximately $3.6 million as of December 31, 2024161162 - The company is currently in compliance with alternate NYSE American listing standards based on market capitalization and public float, but there is no guarantee this will continue162 Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities during the period covered by this report - There were no unregistered sales of equity securities or purchases of equity securities by the issuer during the reporting period164 Other Information During the fiscal quarter ended March 31, 2025, no director or Section 16 officer adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement - No director or officer adopted, modified, or terminated a Rule 10b5-1 trading arrangement during the fiscal quarter ended March 31, 2025166 Exhibits This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, forms of warrants and securities purchase agreements from recent financing, and officer certifications
MAIA Biotechnology(MAIA) - 2025 Q1 - Quarterly Report